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BAM Group LLC d/b/a VapEscape manufactured and distributed e-liquid tobacco products without obtaining required premarket authorization from the FDA. The company failed to comply with the Family Smoking Prevention and Tobacco Control Act, which requires all "new tobacco products"—including e-liquids and electronic nicotine delivery systems deemed tobacco products as of August 8, 2016—to have FDA premarket approval before commercial distribution in the United States. The warning letter indicated the company's e-liquid products were being sold or offered for sale without the necessary premarket authorization mandated under section 910(a) of the Federal Food, Drug, and Cosmetic Act.